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ACTIVE NOT RECRUITINGPhase2

Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

NCT ID: NCT03997643

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Radiotherapy to all dissected areas (radiation), Omit radiation to pN0 neck (radiation)
How long the study runs
Study runs about 96 months (dates as stated)
About the drug or intervention
Radiotherapy to all dissected areas — radiation: Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas · Omit radiation to pN0 neck — radiation: post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
90
Started
2019-09-06
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for head and neck cancer
  • • Phase2 - 90 participants
  • • The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with head and neck cancer

Where?

  • • Glasgow - Beatson West of Scotland Cancer Centre

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

More detail

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options. The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location). Patients will be followed for a total of 5 years.

Head and Neck Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

node negative

What the study is looking for

  • ✓Willing to provide agreement to take part
  • ✓ECOG performance status 0-2
  • ✓confirmed by a biopsy, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck...
  • ✓Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0...

Who cannot take part

  • ✗Serious medical other health conditions or other contraindications to radiotherapy
  • ✗Prior history of head and neck cancer within 5 years
  • ✗Any other active invasive cancer, except non-melanotic skin cancers
  • ✗Prior head and neck radiation at any time
  • ✗Prior oncologic head and neck surgery in the oral cavity or neck
See the full criteria
Inclusion Criteria: * Willing to provide informed consent * ECOG performance status 0-2 * Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection * Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician * Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck Exclusion Criteria: * Serious medical comorbidities or other contraindications to radiotherapy * Prior history of head and neck cancer within 5 years * Any other active invasive malignancy, except non-melanotic skin cancers * Prior head and neck radiation at any time * Prior oncologic head and neck surgery in the oral cavity or neck * Metastatic disease * Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy * Inability to attend full course of radio therapy or follow-up visits * Unable or unwilling to complete QoL questionnaires * Pregnant or lactating women

Where Is This Study? (1 UK site)

Beatson West of Scotland Cancer Centre

Glasgow G12 OYN, United Kingdom

Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718
Data sourced from ClinicalTrials.gov · Last verified: 2026-09